Duns Number:688454128
Device Description: The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure rightarmpit temperature. Its operation is based on measuring the natural thermal radiation emanatingfrom the armpit and the adjacent surfaces. Its software performs a calculation that factors in roomtemperature, and then a calculated temperature is displayed on the mobile device.Purpose of measuring body temperature is to check body condition by measuring correcttemperature in important part of body and both measured room temperature and relative humidityare to show environmental conditions.In case of right armpit measurement, this product searches the highest temperature from the rightarmpit.
Catalog Number
-
Brand Name
Fever Garde
Version/Model Number
HMT-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191978
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
bdf0baef-11f6-44af-976b-2940bfea9912
Public Version Date
April 21, 2022
Public Version Number
1
DI Record Publish Date
April 13, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |